BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DSL ACTIVE ALDOSTERONE RIA (DSL 8600)

    K Number: K943397 · Decision Feb 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    11
    Applicant Total
    94
    Review Days
    214

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    Basic Information

    Device Name
    DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
    K Number
    K943397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1045
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    July 14, 1994
    Decision Date
    February 13, 1995
    Product Code
    CJM
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CJM Radioimmunoassay, Aldosterone

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    K001086 FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
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    K981871 C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
    K973243 ACTIVE PSA ELISA (DSL-10-9700)
    K973244 ACTIVE PSA IRMA (DSL-9700)
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